(33 days)
Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Norian SRS Bone Void Filler is an injectable, moldable, and biocompatible bone void filler. The Reactants Pack contains sterile powder (calcium phosphate) and a syringe that contains sterile solution (dilute sodium phosphate). The Reactants Pack is designed to be placed in a reusable mixer where the 2 components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18°-23°C / 64°- 73°F. At body temperature (37°C / 98.6°F), Norian SRS Bone Void Filler begins to harden after 2 minutes and sets in approximately 10 minutes. Norian SRS Bone Void Filler is slowly resorbed and replaced by bone over a period of years.
The provided text is a 510(k) summary for the Norian SRS Bone Void Filler. This document describes a medical device and its intended use, but it does not contain information about acceptance criteria, device performance studies, or ground truth establishment for an AI/CADe device.
The document states: "Norian SRS Bone Void Filler is equivalent to the predicate device in terms of material composition, physical properties, and performance characteristics." This implies that the device's performance was compared to a previously approved predicate device, but it does not detail any specific acceptance criteria or a study design like those typically associated with evaluating AI/CADe systems.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. This information is usually found in performance data sections of 510(k) submissions for AI/CADe devices, which this document is not.
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K 060408
3. 510(k) Summary
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380 |
|---|---|
| Contact: | Angela SilvestriSynthes (USA)1230 Wilson DriveWest Chester, PA 19380(484) 356-9728 |
| Device Name: | Norian SRS Bone Void Filler |
| Device Classification: | 87 MQV - Class II - Filler, Bone Void, Calcium Compound |
| Device Description: | Norian SRS Bone Void Filler is an injectable, moldable, andbiocompatible bone void filler. The Reactants Pack contains sterilepowder (calcium phosphate) and a syringe that contains sterilesolution (dilute sodium phosphate). The Reactants Pack is designed tobe placed in a reusable mixer where the 2 components are mixedtogether to form a smooth, viscous paste that remains injectable forapproximately 5 minutes at 18°-23°C / 64°- 73°F. At body temperature(37°C / 98.6°F), Norian SRS Bone Void Filler begins to harden after 2minutes and sets in approximately 10 minutes. Norian SRS Bone VoidFiller is slowly resorbed and replaced by bone over a period of years. |
| Indications for use: | Norian SRS Bone Void Filler is intended only for bony voids ordefects that are not intrinsic to the stability of the bony structure.Norian SRS Bone Void Filler is intended to be placed or injected intobony voids or gaps of the skeletal system (the extremities and pelvis).These defects may be surgically created osseous defects or osseousdefects created from traumatic injury to the bone. The productprovides a bone void filler that resorbs and is replaced with boneduring the healing process. |
| Predicate Device | Norian SRS Bone Void Filler is not intended for use in the spine andshould not be used in the presence of active or suspected infection. |
| Predicate Device | Norian SRS Bone Void filler, K011897 |
| Substantial EquivalenceDetermination | Norian SRS Bone Void Filler is equivalent to the predicate device interms of material composition, physical properties, and performancecharacteristics. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of an eagle or bird-like figure, with three distinct, curved lines suggesting wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 ] 2006
Synthes (USA) c/o Ms. Angela J. Silvestri Group Manager, Regulatory Affairs 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K060408
Trade/Device Name: Norian SRS Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: February 15, 2006 Received: February 16, 2006
Dear Ms. Silvestri:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Angela J. Silvestri
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Helen Lummus
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 2.
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K060408 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Norian SRS Bone Void Filler Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities to be placed or myseles may be surgically created osseous defects or osseous defects and pervisy. There as sinjury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Contraindications:
Norian SRS Bone Void Filler is not intended for use in the spine and should not be used in the presence of active or suspected infection
Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hole Lemun a
Division of General, Restorative, and Neurological Devices
510(k) Number K06408
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.